feasibility of a sleep improvement intervention for weight loss and its maintenance in sleep impaired obese adults

Conditions: Obesity

Summary: the primary objective of the proposed study is to develop, deliver and assess the feasibility and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients. secondary objectives are to demonstrate that a targeted behavioral sleep intervention can improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary modification program; and to demonstrate that a targeted behavioral sleep intervention enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle and dietary modification program. those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep quality \[\ 03:00 on weekdays\]) who are also obese (body mass index \[bmi\] ≥27.5 kg/m2) will be recruited and randomized to a 12-week weight loss intervention with/without sleep improvement. volunteers will be followed for a further six months to assess multiple outcome measures. it is hypothesised that inclusion of a targeted behavioral sleep improvement intervention will be feasible and acceptable and will enhance immediate and long-term treatment outcomes of obese adults enrolled to a lifestyle and dietary modification program. the results of the study will be used to better inform the design and development of a future randomized controlled trial (rct). sleep improvement may be incorporated into weight management treatments as a cost-effective alternative/addition.

the primary objective of the proposed study is to develop, deliver and assess the feasibility and adherence to a targeted behavioral sleep intervention for sleep impaired obese patients. secondary objectives are to demonstrate that a targeted behavioral sleep intervention can improve treatment outcomes in obese adult outpatients enrolled to a lifestyle and dietary modification program; and to demonstrate that a targeted behavioral sleep intervention enhances the long-term maintenance of treatment gains in obese adults enrolled in a lifestyle and dietary modification program. those with sleep impairment (sleep duration of ≤6.5hours per 24-hours; and/or poor sleep quality \[\ 03:00 on weekdays\]) who are also obese (body mass index \[bmi\] ≥27.5 kg/m2) will be recruited and randomized to a 12-week weight loss intervention (based on a previously developed specialist lifestyle management program) with/without sleep improvement (based on a cognitive behaviour treatment developed to treatment sleep problems in us military). volunteers will be followed for a further six months to assess multiple outcome measures. other secondary measures to be assessed are mood (hospital anxiety depression scale \[hads\], food intake (24-hour food recall), quality of life (iwqol-lite \& eq-5d), and sleep (psqi \& ru_sated), all of which will be assessed using validated questionnaires that have been previously assessed for reliability. it is hypothesised that inclusion of a targeted behavioral sleep improvement intervention will be feasible and acceptable and will enhance immediate and long-term treatment outcomes of obese adults enrolled to a lifestyle and dietary modification program. the results of the study will be used to better inform the design and development of a future randomized controlled trial (rct). sleep improvement may be incorporated into weight management treatments as a cost-effective alternative/addition.

Eligibility criteria:
inclusion criteria: * sleep impaired individuals defined as meeting one or more of the following objectively estimated sleep feature: 1) ≤6.5hours per 24-hours; 2) poor sleep quality (\ 03:00 on weekdays); * obese (bmi ≥27.5 kg/m2 for asians/arabs or bmi ≥30.0 kg/m2 for europeans/caucasians); * men/women; * age 18-50 years (upper age limit chosen due to specific alterations in sleep duration and quality commonly observed after this age); * good english language comprehension/communication skills; * able to provide informed consent and willing to participate in the study. exclusion criteria: * currently taking medication(s) that may interfere with weight loss (e.g. corticosteroids); * contraindications to use of the cambridge weight plan (heart attack or stroke three months preceding study participation; lactose intolerance; gallstones; porphyria; active gout); * medications that may interfere with sleep; * clinically diagnosed sleep disorder(s) or those at high risk of undiagnosed osa based on three questionnaires (berlin, ess, stop-bang); * chronic illness (asthma, copd, diabetes, arthritis, fibromyalgia, heart condition, kidney or liver disease); * uncontrolled hypertension; * polycystic ovary syndrome; * endocrine disorder(s), except for stable treated hypothyroidism; * psychiatric disorder(s), except for stable treated depression; * currently taking monoamine oxidase inhibitor medication; * previous/planned bariatric surgery; * diagnosed eating disorders; * night-shift workers; * substance use; * excessive alcohol consumption; * known pregnancy or planned pregnancy during the study/breastfeeding or given birth in last 3 months; * family circumstances e.g. infants, young children, pets that will make study adherence difficult.

Keywords: sleep